Patient leaflet - Edoxaban Krka 60 mg film-coated tablets
1. What Edoxaban is and what it is used for
Edoxaban contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. This medicine helps to prevent blood clots from forming. It works by blocking the activity of factor Xa, which is an important component of blood clotting.
Edoxaban is used in adults to:
- prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor, such as heart failure, previous stroke or high blood pressure;
- treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels in the lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels in the legs and/or lungs.
2. What you need to know before you take Edoxaban
Do not take Edoxaban
- if you are allergic to edoxaban or any of the other ingredients of this medicine (listed in section 6);
- if you are actively bleeding;
- if you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, or recent surgery of the brain or eyes);
- if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open;
- if you have a liver disease which leads to an increased risk of bleeding;
- if you have uncontrolled high blood pressure;
- if you are pregnant or breast feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Edoxaban.
if you have an increased risk of bleeding, as could be the case if you have any of the following conditions:
- endstage kidney disease or if you are on dialysis;
- severe liver disease;
- bleeding disorders;
- a problem with the blood vessels in the back of your eyes (retinopathy); - recent bleeding in your brain (intracranial or intracerebral bleeding); - problems with the blood vessels in your brain or spinal column;
if you have a mechanical heart valve.
Edoxaban 15 mg is only to be used when changing from Edoxaban 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3. How to take Edoxaban).
Take special care with Edoxaban,
- if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk for blood clots), tell your doctor who will decide if the treatment may need to be changed.
If you need to have an operation,
- it is very important to take Edoxaban before and after the operation exactly at the times you have been told by your doctor. If possible, Edoxaban should be stopped at least 24 hours before an operation. Your doctor will determine when to restart Edoxaban.
In emergency situations your physician will help determine the appropriate actions regarding Edoxaban.
Children and adolescents
Edoxaban is not recommended in children and adolescents under 18 years of age.
Other medicines and Edoxaban
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking any of the following:
- some medicines for fungal infections (e.g. ketoconazole);
- medicines to treat abnormal heart beat (e.g. dronedarone, quinidine, verapamil);
- other medicines to reduce blood clotting (e.g. heparin, clopidogrel or vitamin K antagonists such as warfarin, acenocoumarol, phenprocoumon or dabigatran, rivaroxaban, apixaban);
- antibiotic medicines (e.g. erythromycin, clarithromycin);
- medicines to prevent organ rejection after transplantation (e.g. ciclosporin);
- anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid);
- antidepressant medicines called selective serotonin reuptake inhibitors or serotonin- norepinephrine reuptake inhibitors;
If any of the above apply to you, tell your doctor before taking Edoxaban, because these medicines may increase the effects of Edoxaban and the chance of unwanted bleeding. Your doctor will decide, if you should be treated with Edoxaban and if you should be kept under observation. If you are taking any of the following:
- some medicines for treatment of epilepsy (e.g. phenytoin, carbamazepine, phenobarbital);
- St John’s Wort, a herbal product used for anxiety and mild depression;
- rifampicin, an antibiotic medicine.
If any of the above apply to you, tell your doctor before taking Edoxaban, because the effect of Edoxaban may be reduced. Your doctor will decide if you should be treated with Edoxaban and if you should be kept under observation.
Pregnancy and breast-feeding
Do not take Edoxaban if you are pregnant or breast-feeding. If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Edoxaban. If you become pregnant while you are taking Edoxaban, immediately tell your doctor, who will decide how you should be treated.
Driving and using machines
Edoxaban has no or negligible effects on your ability to drive or use machines.
Edoxaban contains dextrates (glucose)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Edoxaban
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
The recommended dose is one 60 mg tablet once daily.
If you have impaired kidney function, the dose may be reduced to one 30 mg tablet once daily by your doctor;
- if your body weight is 60 kg or lower, the recommended dose is one 30 mg tablet once daily;
if your doctor has prescribed medicines known as P-gp inhibitors:
ciclosporin, dronedarone, erythromycin, or ketoconazole, the recommended dose is one 30 mg tablet once daily.
How to take the tablet
Swallow the tablet, preferably with water.
Edoxaban can be taken with or without food.
If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Edoxaban. The tablet may be crushed and mixed with water or apple puree immediately before you take it. If necessary, your doctor may also give you the crushed Edoxaban tablet through a tube via the nose (nasogastric tube) or a tube in the stomach (gastric feeding tube). Your doctor may change your anticoagulant treatment as follows:
Changing from vitamin K antagonists (e.g. warfarin) to Edoxaban Stop taking the vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to start taking Edoxaban. Changing from non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) to Edoxaban
Stop taking the previous medicines (e.g. dabigatran, rivaroxaban, or apixaban) and start Edoxaban at the time of the next scheduled dose. Changing from parenteral anticoagulants (e.g. heparin) to Edoxaban Stop taking the anticoagulant (e.g. heparin) and start Edoxaban at the time of the next scheduled anticoagulant dose.
Changing from Edoxaban to vitamin K antagonists (e.g. warfarin) If you currently take 60 mg Edoxaban:
Your doctor will tell you to reduce your dose of Edoxaban to a 30 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to stop taking Edoxaban.
If you currently take 30 mg (dose reduced) Edoxaban:
Your doctor will tell you to reduce your dose of Edoxaban to a 15 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to stop taking Edoxaban.
Changing from Edoxaban to non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban)
Stop taking Edoxaban and start the non-VKA anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Edoxaban.
Changing from Edoxaban to parenteral anticoagulants (e.g. heparin) Stop taking Edoxaban and start the parenteral anticoagulant (e.g. heparin) at the time of the next scheduled dose of Edoxaban.
Patients undergoing cardioversion:
If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take Edoxaban at the times your doctor tells you to prevent blood clots in the brain and other blood vessels in your body. If you take more Edoxaban than you should
Tell your doctor immediately if you have taken too many Edoxaban tablets. If you take more Edoxaban than recommended, you may have an increased risk of bleeding.
If you forget to take Edoxaban
You should take the tablet immediately and then continue the following day with the once daily tablet as usual. Do not take a double dose on the same day to make up for a forgotten tablet.
If you stop taking Edoxaban
Do not stop taking Edoxaban without talking to your doctor first, because Edoxaban treats and prevents serious conditions.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other similar medicines (medicines to reduce blood clotting), Edoxaban may cause bleeding which may potentially be life-threatening. In some cases the bleeding may not be obvious.
If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately.
Your doctor may decide to keep you under closer observation or change your medicine.
Overall list of possible side effects:
Common (may affect up to 1 in 10 people)
- stomach ache;
- abnormal liver blood tests;
- bleeding from the skin or under the skin;
- anaemia (low levels of red blood cells);
- bleeding from the nose;
- bleeding from the vagina;
- rash;
- bleeding in the bowel;
- bleeding from the mouth and/or throat;
- blood found in your urine;
- bleeding following an injury (puncture);
- bleeding in the stomach;
- dizziness;
- feeling sick;
- headache;
- itching.
Uncommon (may affect up to 1 in 100 people):
- bleeding in the eyes;
- bleeding from a surgical wound following an operation;
- blood in the spit when coughing;
- bleeding in the brain;
- other types of bleeding;
- reduced number of platelets in your blood (which can affect clotting);
- allergic reaction;
- hives.
Rare (may affect up to 1 in 1000 people)
- bleeding in the muscles;
- bleeding in joints;
- bleeding in the abdomen;
- bleeding in the heart;
- bleeding inside the skull;
- bleeding following a surgical procedure;
- allergic shock;
- swelling of any part of the body due to allergic reaction. Not known (frequency cannot be estimated from the available data)
- bleeding in the kidney sometimes with presence of blood in urine leading to inability of the kidneys to work properly (anticoagulant-related nephropathy).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme
Website: yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Edoxaban
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. This medicine does not require any special temperature storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Edoxaban contains
The active substance is edoxaban.
Each tablet contains edoxaban tosylate monohydrate equivalent to 15 mg edoxaban.
Each tablet contains edoxaban tosylate monohydrate equivalent to 30 mg edoxaban.
Each tablet contains edoxaban tosylate monohydrate equivalent to 60 mg edoxaban.
The other ingredietnts (excipients) are dextrates (glucose), pregelatinized starch (maize origin), crospovidone, hydroxypropylcellulose and magnesium stearate (E470b) in the tablet core and hypromellose, talc, macrogol, titanium dioxide (E 171), iron oxide yellow (E 172) – only for 15 mg and 60 mg and iron oxide red (E 172) – only for 15 mg and 30 mg in the film coating layer.
See section 2 ‘’Edoxaban contains dextrates (glucose).’’ What Edoxaban looks like and contents of the pack
Edoxaban 15 mg film-coated tablets are light brownish orange, round, biconvex, film-coated tablets, marked with E1 on one side of the tablet. Tablet dimension: diameter approx. 6 mm.
Edoxaban 30 mg film-coated tablets are pink, round, biconvex, film-coated tablets, marked with E2 on one side of the tablet. Tablet dimension: diameter approx. 8 mm.
Edoxaban 60 mg film-coated tablets are brownish yellow, round, biconvex, film-coated tablets, marked with E3 on one side of the tablet. Tablet dimension: diameter approx. 10 mm.
Edoxaban 15 mg film-coated tablets are available in packs containing
- 10 film-coated tablets, in blisters.
- 10 x 1 film-coated tablet, in perforated unit dose blisters. Edoxaban 30 mg and 60 mg film-coated tablets are available in packs containing
- 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets, in blisters.
- 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1 or 100 x 1 film-coated tablet, in perforated unit dose blisters.
- 14, 28, 56, 84 or 98 film-coated tablets, in blisters, calendar pack.
- 14 x 1, 28 x 1, 56 x 1, 84 x 1 or 98 x 1 film-coated tablet, in perforated unit dose blisters, calendar pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany This leaflet was last revised in 10/2024.
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MIMMIMI 385 mm ± 0,5 mm smer branja kode/direction of reading PhC